Faculty Bibliography

Introduction: Missed adenomas during screening and surveillance colonoscopy are considered a leading cause of interval colorectal cancer (CRC). Numerous technologies were developed to assist in visualization of the mucosal surface and particularly the proximal aspect of haustral folds, consisting of either rear-viewing optics or mechanical manipulation of colon folds. Recent studies demonstrate superiority in increasing adenoma detection rate (ADR) of mechanical fold manipulation over rearview optical visualization, by two mechanical attachments at the distal tip of the colonoscope (Figure 1) - the Endocuff Vision single-use disposable attachment (ECV, Olympus Corporation, Japan) and the G-EYE permanently-mounted reusable and reprocessable balloon (G-EYE, Smart Medical Systems, Israel). The ECV is placed on the colonoscope tip prior to insertion, and is designed to expand radially during withdrawal, thereby allowing manipulation of folds. The G-EYE balloon is deflated during insertion, inflated at the cecum, engaging the colon wall and flattening colon folds during withdrawal, while centralizing colonoscopic view.
Method(s): Randomized, prospective, multicenter study, patients referred to screening or surveillance colonoscopy were randomized to undergo either ECV or G-EYE colonoscopy. A 1:1 randomization ratio between ECV and G-EYE colonoscopy was done. Polyps were removed, sent for pathology and analyzed, to determine the adenoma detection rate (ADR) and adenoma per patient (APP) in each group.
Result(s): 727 enrolled patients out of planned 970 (485 in each group) are presented (Table 1), 364 in the ECV group and 363 in the G-EYE group. Patient characteristics were similar in both groups. Withdrawal times were above the recommended 6-minute guideline threshold and similar in both arms. ADR in the G-EYE arm was 9.8% higher (relative increase 19.1%) than in the ECV arm, and the detection of advanced adenomas was doubled (24% versus 12%). The number of adenomas per patient was significantly higher for G-EYE colonoscopy, particularly the number of advanced and large adenomas.
Conclusion(s): This randomized trial is the first head to head comparison of these mechanical enhancement colonoscopy devices. In this present study G-EYE (preliminary analysis) demonstrated meaningful increase in ADR over ECV, particularly for advanced adenomas, as well as substantial increase in APP

Introduction: Endoscopic ultrasound (EUS with fine needle aspiration (FNA) is often used to evaluate solid tumors of the pancreas. However, fine needle biopsy (FNB) offers a histologic sample versus a disaggregated sample seen in FNA. Even with FNB technique can limit sample quality. All current needles are manually operated. However, there is a novel motorized FNB needle offering a rotational axial motion resulting in an intact core. This case demonstrates the use of a motorized FNB needle for tissue sampling during EUS. Case Description/Methods: A 87 F presents for the work up of abdominal pain and weight loss. She has no significant medical problems. A cat scan of the abdomen and pelvis was ordered revealing a 3.5 cm mass in the body of the pancreas, concerning for neoplasm. The patient was sent for EUS with biopsy for tissue diagnosis. During the EUS exam a 19g motorized FNB needle was used. After the needle is passed into the tumor a button on the needle shaft is pressed. The needle begins to rotate using an electro mechanical axial motion cutting into the tumor to obtain a specimen. A single pass was required, which confirmed a ductal adenocarcinoma of the pancreas. Due to the vascular invasion the patient was sent to oncology for further management.
Discussion(s): Cancer management continuous to move in the direction of precision medicine. A tissue biopsy is needed to have intact histology sample for diagnosis of a malignant tumor. Furthermore, biopsy is needed to allow molecular analysis of the tumor to offer a personalized treatment plan. This is the first reported case of a motorized EUS needle for tissue acquisition. Future studies are needed to assess performance against traditional manual EUS needles

Introduction: Obtaining core biopsies using endoscopic ultrasound-guided fine-needle biopsy (EUSFNB) needles for histological diagnosis and tumor molecular profiling is needed in the era of precision medicine. However, sample quality is impacted by several factors; needle type, number of passes and technique. Currently, all available biopsy needles are manually operated. A new motorized endoscopic ultrasound electro-mechanical revolving needle has been developed to standardize and improve tissue acquisition. This unique cutting needle design along with the rotation-axial motion produces smooth tissue cutting and intact core-tissue quality, without crushing the samples. The combination of the axial and the rotational movements enables efficient and smooth tissue cutting, producing better core-tissue quality and volume. The study is the first to compare a motorized approach to traditional manual technique.
Method(s): Patients with solid pancreas tumors or lymphadenopathy were eligible for enrollment. Each patient had the lesion sampled by both motorized needle (19g) and manual needle (Sharkcore), 22g, biopsy method. The study was approved by the IRB. Procedure measures included; number of passes, diagnostic yield, and histologic scores. Microscopic grading scale of the histological quality of the specimen from 1 to 5 scale (1 =poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield).
Result(s): Ten patients were enrolled, 7males and 3 females, with an average age of 71 years old. There were 9 pancreas tumors with an average size of 30 mm and one lymph node (30mm). The average number of passes was 1 in motorized group compared to 1.5 in manual group. The diagnostic yield was similar in both arms. However, histologic scores and ability for molecular profiling was higher in the automated group at 100% and 96% compared to 73% and 60% in the manual group (Figure 1).
Conclusion(s): FNB is the method of choice for tumor acquisition. The initial results of this study suggest an automated motorized needle biopsy approach may lead to more consistent histologic quality along with the ability for molecular profiling of tumors with fewer passes. Future larger studies are need to validate these findings. This is the first human feasibility trial using a motorized needle during endoscopic ultrasound

Introduction: Combination endoscopic therapy is considered a gold standard treatment of upper gastrointestinal bleeding (UGIB). Endoscopic therapy reduces mortality in these patients. Hemospray is a haemostatic powder used for the endoscopic treatment of GI bleeds. We aimed to analyse the outcomes of Hemospray therapy in combination with standard endoscopic treatments. Aims & Methods: Data was collected on consecutive patients with GIB's and treated with Hemospray as part of a combination with standard endoscopic treatments from 18 centres (USA, UK, France, Germany, Spain). The decision to use Hemospray and what combination to use was at the discretion of the endoscopist.
Result(s): We analysed the outcomes of 230 patients (UGIB's - 134 peptic ulcers, 37 post endoscopic therapy, 29 UGI malignancies, 7 variceal, 6 angiodysplasia, 2 inflammation, 15 lower GI bleeds) (Table 1). 134/267 (50%) of the peptic ulcer cohort were treated with Hemospray combination therapy. Haemostasis rates of 92% were achieved relative to 89% in the overall peptic ulcer bleed cohort. 20/108 (19%) had a rebleed and 30-day mortality of 17% (20/119). The most common combination therapy was Hemospray with adrenaline injection therapy with a haemostasis rate of 93% (49/53). Hemospray was used as a second modality in 36/66 (55%) cases. In the remaining cases it was used as a 3rd modality, and a 4thmodality in one case. 58% of all patients had Forrest 1b ulcers where a haemostasis rate of 91% was achieved, re-bleeding in 12/69 (17%). 18% of patients had Forrest 1a ulcers with immediate haemostasis in 21/24 (88%) patients, re-bleed in 4/18 (22%) patients. In the post endoscopic therapy cohort, a 100% haemostasis rate was achieved with a 4% (1/26) re-bleed. Most of the cases were post endoscopic mucosal resection (22/37, 59%). The most common combination therapy was Hemospray and adrenaline injection (24% of patients). In malignancy related UGIB's an 86% (25/29) haemostasis rate was achieved, with a rebleed rate of 17% (4/23). The most common combination was Hemospray and adrenaline injection therapy (12/29, 41%) where a 92% haemostasis rate was achieved and one re-bleed. In variceal bleeds (5 oesophageal, 2 gastric) a haemostasis rate of 86% (6/7) was achieved, a rebleed rate of 29%. Hemospray was used as the second modality to banding/glue injection in the majority of cases.
Conclusion(s): High haemostasis rates were achieved following treatment with Hemospray in all the subgroups. In peptic ulcers high haemostasis and reasonable re-bleeding rates were achieved in Forrest 1a/1b ulcers. Results show that Hemospray combination therapy can have a role in lower GI bleeds. There is a shift towards use of Hemospray as part of standard combination therapy. Its role needs to be clearly defined within the GI bleed algorithm. Disclosure: M.H - Speaker fees (Cook Medical), R.H - Received research grant support from Pentax Medical, Cook Endoscopy, Fractyl Ltd, C2 therapeutics and Medtronic to support research infrastructure

BACKGROUND AND AIM/OBJECTIVE:Recently, the BLI Adenoma Serrated International Classification (BASIC) system was developed by European experts to differentiate colorectal polyps. Our aim was to validate the BASIC classification system among the US-based endoscopy experts. METHODS:Participants utilized a web-based interactive learning system where the group was asked to characterize polyps using the BASIC criteria: polyp surface (presence of mucus, regular/irregular and [pseudo]depressed), pit appearance (featureless, round/non-round with/without dark spots; homogeneous/heterogeneous distribution with/without focal loss), and vessels (present/absent, lacy, peri-cryptal, irregular). The final testing consisted of reviewing BLI images/videos to determine whether the criteria accurately predicted the histology results. Confidence in adenoma identification (rated "1" to "5") and agreement in polyp (adenoma vs non-adenoma) identification and characterization per BASIC criteria were derived. Strength of interobserver agreement with kappa (k) value was reported for adenoma identification. RESULTS:Ten endoscopy experts from the United States identified conventional adenoma (vs non-adenoma) with 94.4% accuracy, 95.0% sensitivity, 93.8% specificity, 93.8% positive predictive value, and 94.9% negative predictive value using BASIC criteria. Overall strength of interobserver agreement was high: kappa 0.89 (0.82-0.96). Agreement for the individual criteria was as follows: surface mucus (93.8%), regularity (65.6%), type of pit (40.6%), pit visibility (66.9%), pit distribution (57%), vessel visibility (73%), and being lacy (46%) and peri-cryptal (61%). The confidence in diagnosis was rated at high ≥4 in 67% of the cases. CONCLUSIONS:A group of US-based endoscopy experts hsave validated a simple and easily reproducible BLI classification system to characterize colorectal polyps with >90% accuracy and a high level of interobserver agreement.

Introduction: Looping is a primary barrier to safe and efficient colonoscopy. Common methods to address looping include staff-applied manual pressure and patient repositioning. These techniques are used frequently (52% and 34% of colonoscopies, respectively) yet are variably effective and can cause musculoskeletal disorders (MSDs) in endoscopy staff. A recent study demonstrated an association between manual pressure and post-procedure musculoskeletal pain in endoscopy personnel. Risk was maximized when long-duration pressure (> 3 min) was needed in obese patients (BMI> 30). ColoWrap (ColoWrap, LLC, Durham, NC) is an anti-looping compression device applied during colonoscopy to decrease insertion time and the need for manual pressure and patient repositioning. We aimed to determine the extent to which the device reduces the need for manual pressure and repositioning relative to published rates.
Method(s): This retrospective, multi-center, observational chart review included patients that underwent colonoscopy with the ColoWrap device between July 28, 2016 and November 11, 2020.The primary outcome was use of manual pressure. Secondary outcomes included the use of manual pressure for> 3 minutes and the use of patient repositioning.
Result(s): 392 procedures were included in the review. The population was predominantly male (61%), over 60 (mean age: 62.4+/-10.2), and obese (mean BMI: 33.4+/-8.2). 29 patients (7.4%) presented with an abdominal hernia. 65 (16.6%) had at least one prior abdominal surgery. Propofol sedation was used in the majority (59%) of procedures. Cecal intubation was achieved in 392 cases (100%). Mean cecal intubation time was 6.3+/-5.1 (min). Manual pressure was required in 39 cases (9.9%) and only 6 procedures (1.5%) required manual pressure for> 3 min. Patient repositioning was required in 22 cases (5.6%). In a sub-population analysis of obese patients with BMI> 35 (n=134), manual pressure was required in 10 procedures (7.5%); 2 procedures (1.5%) required manual pressure> 3 min and 5 procedures (3.7%) needed patient repositioning.
Conclusion(s): Use of the ColoWrap colonoscopy compression device significantly reduced the use of manual pressure and patient repositioning relative to published rates. The device essentially eliminated the need for long-duration manual pressure and was comparably effective in obese patients with BMI> 35

BACKGROUND:High quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy. METHODS:This multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation. RESULTS:Ninety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu. CONCLUSIONS:In this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings. Trial registration Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).

We describe 2 cases in which video capsule endoscopy was performed remotely using TeleInGEstion Remote Video Capsule Endoscopy (TIGER VCE), given limited access to endoscopy during the COVID-19 pandemic. The patients ingested the CapsoCam capsule during a televisit, and the video was subsequently reviewed remotely by the physician. TIGER VCE was used to diagnose a benign etiology of melena and used to confirm a diagnosis of Crohn's disease before the initiation of biologic therapy. These cases demonstrate the safety and efficacy of TIGER VCE. We feel that this technique may be considered as a standard ingestion technique in the future.

GOAL/OBJECTIVE:This meta-analysis aims to compare the sessile-serrated adenoma detection rate (SSADR) of currently available mechanical new technology devices (NTDs) to conventional colonoscopy (CC). BACKGROUND:NTDs including Endocuff, EndoRing, G-Eye, and AmplifEYE were developed with the aim of improving adenoma detection rate by enhancing colonic mucosal visualization. Increasing awareness of the risk of sessile-serrated adenoma progression to malignancy has ushered a need to increase the detection of these characteristically flat lesions. STUDY/METHODS:Embase and PubMed/Medline databases were searched from inception through January 2019 for published manuscripts or major conference abstracts reporting SSADR with Endocuff, EndoRing, G-Eye, AmplifEYE, and CC. Randomized controlled trials, high-quality case-control, cohort, and observational studies in adults with >10 subjects were included. The primary outcome was pooled SSADR odds ratio (ORs) with 95% confidence interval (95% CI) comparing CC with the NTDs. In addition, an analysis comparing each device to CC was performed. RESULTS:Of 207 citations identified, a total of 14 studies with 12,655 subjects were included in our analysis (5931 subjects with NTDs and 6724 with CC). There were 12 studies with Endocuff, 2 with EndoRing, 1 with G-EYE, and 1 with AmplifEYE. The mean age was 62.4 years and 57.5% were males. Pooled SSADR with NTDs was 12.3% as compared with 6.4% with CC, with an OR of 1.81 (95% CI: 1.6-2.0, I2: 77%). Analysis of Endocuff alone yielded an OR 1.81 (95% CI: 1.6-2.1, I2: 79%). CONCLUSION/CONCLUSIONS:Mechanical NTDs, notably Endocuff, are a safe and effective tool to increase the SSADR.